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Microalbuminuria Predicting CIAKI After CAG (MPCC)

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ClinicalTrials.gov Identifier: NCT02808845
Recruitment Status : Not yet recruiting
First Posted : June 22, 2016
Last Update Posted : June 22, 2016
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
The purpose of this study is to investigate the association between pre-existing microalbuminuria and contrast-induced acute kidney injury (CIAKI) following coronary angiography (CAG).

Condition or disease Intervention/treatment
Contrast-induced Acute Kidney Injury Microalbuminuria Other: microalbuminuria

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pre-existing Microalbuminuria Predicting Contrast-induced Acute Kidney Injury (CIAKI) Following Coronary Angiography (CAG)
Study Start Date : December 2016
Estimated Primary Completion Date : December 2020

Group/Cohort Intervention/treatment
microalbuminuria with eGFR≥60ml/min
microalbuminuria group with estimated glomerular filtration rate (eGFR) ≥60ml/min.
Other: microalbuminuria
normal-albuminuria group with eGFR≥60ml/min
normal-albuminuria group with estimated glomerular filtration rate (eGFR) ≥60ml/min.
microalbuminuria group with eGFR<60ml/min
microalbuminuria group with estimated glomerular filtration rate (eGFR) <60ml/min.
Other: microalbuminuria
normal-albuminuria group with eGFR<60ml/min
normal-albuminuria group with estimated glomerular filtration rate (eGFR) <60ml/min.



Primary Outcome Measures :
  1. changes of serum creatinine (SCr, umol/L) [ Time Frame: 24-48 hours after CAG ]
    the difference of SCr before and after CAG.

  2. number of participants with increase in SCr of at least 44.2 umol/L higher than before [ Time Frame: 24-48 hours after CAG ]
    number of participants with the difference of SCr before and after CAG over 44.2 umol/L.

  3. number of participants with increase of SCr over 25% higher than before [ Time Frame: 24-48 hours after CAG ]
    number of participants with an increase of SCr over 25% higher than before.


Secondary Outcome Measures :
  1. changes of urine albumin to creatinine ratio (ACR, mg/g) [ Time Frame: 24-48 hours after CAG ]
    the difference of ACR before and after CAG



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with eGFR ≥ 30 ml/min and without macroalbuminuria (defined as urine albumin to creatinine ratio (ACR) >300 mg/g) on admission are prepared to accept scheduled invasive coronary angiography during hospitalization.
Criteria

Inclusion Criteria:

  • Patients with eGFR≥30ml/min and without macroalbuminuria undergoing CAG.

Exclusion Criteria:

  • Pregnancy
  • Lactation
  • Allergic history of contrast media
  • Having been received contrast media within 7 days
  • Use of nephrotoxic medications within 7 days
  • eGFR <30 ml/min, macroalbuminuria (ACR >300 mg/g)
  • Renal transplantation, emergent coronary angiography
  • Cardiogenic shock, pulmonary edema
  • Use of intra-aortic balloon pump (IABP) or mechanical ventilation
  • Multiple myeloma and other malignant tumor
  • Life expectancy less than 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808845


Contacts
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Contact: Zhijian Yang, Doctor +86 13809030208 zhijianyangnj@njmu.edu.cn
Contact: Haoyu Meng, Master +86 15805167259 15805167259@163.com

Locations
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China, Jiangsu
First Affiliated Hospital of Nanjing Medical University Not yet recruiting
Nanjing, Jiangsu, China, 210029
Contact: Zhijian Yang, Doctor    +86 13809030208    zhijianyangnj@njmu.edu.vn   
Contact: Haoyu Meng, Master    +86 15805167259    15805167259@163.com   
Principal Investigator: Haoyu Meng, Master         
Principal Investigator: Dingguo Zhang, Doctor         
Sub-Investigator: Yingqiang Du, Master         
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
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Study Chair: Zhijian Yang, Doctor First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital

Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02808845     History of Changes
Other Study ID Numbers: CIAKI-1
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: June 22, 2016
Last Verified: June 2016

Keywords provided by The First Affiliated Hospital with Nanjing Medical University:
coronary angiography
contrast-induced acute kidney injury
microalbuminuria

Additional relevant MeSH terms:
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Acute Kidney Injury
Albuminuria
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Proteinuria
Urination Disorders
Urological Manifestations
Signs and Symptoms